Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction

NCT07686822 · tracked via the Priya Life Science China tracker

Sponsor

Zhejiang Provincial People's Hospital

Phase

Not applicable

Started

2026-09

Last updated

2026-07-07

Condition(s) studied

Chronic Stroke

Investigational drug(s) / intervention(s)

Spinal Cord StimulationMotor Imagery Brain-Computer Interface Rehabilitation Training

Spinal Cord Stimulation: Spinal cord stimulation will be delivered through epidural electrodes implanted at cervical spinal cord levels, typically C3-C7 for upper limb dysfunction. Stimulation parameters will be individually optimized within clinically safe and device-permitted ranges, including frequency, pulse width, amplitude, electrode configuration, and stimulation mode.

Motor Imagery Brain-Computer Interface Rehabilitation Training: Motor imagery brain-computer interface training will use a 64-channel medical-grade electroencephalography cap to acquire scalp EEG signals. Participants will perform motor imagery tasks involving the affected upper limb, such as grasping, elbow extension, or wrist lifting. Sensorimotor rhythm features, especially mu rhythm and beta rhythm event-related desynchronization, will be extracted in real time. When significant event-related desynchronization is detected, the system will trigger external feedback, such as a soft robotic glove or functional electrical stimulation, to assist the affected limb in completing the target movement.

Study summary

This clinical study aims to evaluate the efficacy and safety of spinal cord stimulation combined with non-invasive motor imagery brain-computer interface rehabilitation training in patients with upper limb motor dysfunction after chronic stroke. The study includes an experimental group receiving spinal cord stimulation combined with motor imagery brain-computer interface rehabilitation training and a control group receiving motor imagery brain-computer interface rehabilitation training alone. The primary outcome is upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity. Secondary outcomes include muscle tone, upper limb functional activity, activities of daily living, adverse events, serious adverse events, and exploratory neurophysiological and neuroimaging indicators.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Age 18 to 75 years. * First-ever unilateral supratentorial stroke, either ischemic or hemorrhagic, confirmed by computed tomography or magnetic resonance imaging, resulting in hemiparesis, with disease duration longer than 6 months. * At least one active movement in the wrist or fingers of the affected upper limb, with muscle strength of grade 1 or higher. * Fugl-Meyer Assessment for Upper Extremity score between 10 and 40, indicating moderate upper limb motor impairment. * Change in Fugl-Meyer Assessment score less than 10% within the previous month, indicating a functional plateau. * Clear consciousness and basically normal cognitive function, with Mini-Mental State Examination score of 24 or higher. * Stable clinical condition and ability to understand and cooperate with simple instructions and rehabilitation training. * Written informed consent voluntarily signed by the participant or legal guardian. Exclusion Criteria: * Other neurological diseases that may cause motor dysfunction, such as Parkinson's disease, multiple sclerosis, or spinal cord injury. * Severe visual or auditory impairment that prevents cooperation with visual or auditory feedback instructions of the brain-computer interface system. * Contraindications to spinal cord stimulation surgery, such as severe coagulation dysfunction, infection at the puncture site, severe spinal deformity, or spinal canal stenosis. * History of epilepsy, intracranial metal implants, cardiac pacemaker, or other contraindications to magnetic resonance imaging. * Previous neuromodulation surgery for hemiparesis, such as spinal cord stimulation or deep brain stimulation. * Pregnancy or lactation. * Any other condition judged by the investigator to make the participant unsuitable for this study.

Primary outcome measure(s)

Change in Fugl-Meyer Assessment for Upper Extremity Score — Baseline, Week 4, Week 8, and Week 12
The Fugl-Meyer Assessment for Upper Extremity will be used to evaluate motor function recovery of the affected upper limb.

Trial sites (1)

Facility	City	Region	Status
Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07686822 on ClinicalTrials.gov ↗ ← All trials in China